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Sanofi Pasteur MSD Limited
Block A, Second Floor, Cookstown Court, Old Belgard Road, Tallaght, Dublin 24,
Telephone: +353 1 468 5600
Fax: +353 1 420 3588
Medical Information Direct Line: +44 (0)1628 587 693
Medical Information e-mail: medinfo@spmsd.com
Medical Information Facsimile: +44 (0)1628 635 072
Summary of Product Characteristics last updated on medicines.ie: 20/05/2010
SPC PNEUMOVAX® II

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20/05/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-May-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 4.4 to add precautionary statement on use of the vaccine in elderly

Section 4.5 To include information about the concomitant administration of Pneumovax® II with Zostavax

Section 4.8 Safety update  to adverse events in elderly
updated to add adverse events i.e. 'febrile convulsions', 'Immune system disorders: anaphylactoid reactions, angioneurotic oedema,  serum sickness' and ' Local injection site reactions may be accompanied by systemic signs and symptoms'.
Updated on 12/08/2008 and displayed until 20/05/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   05/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
The SPC has been updated following a variation to amend the wording regarding revaccination and to add Leukocytosis as an AE.
Updated on 30/04/2008 and displayed until 12/08/2008
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   12/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 6.3 - the shelf life has been adjusted
Updated on 21/09/2007 and displayed until 30/04/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   08/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.4. - updated to include an additional vaccination statement.
 
Section 4.8. - updated to include additional adverse events.
Updated on 20/03/2007 and displayed until 21/09/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   02/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 7 - Changed the address of the marketing authorisation holder.
Updated on 25/05/2006 and displayed until 20/03/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Updated on 16/05/2005 and displayed until 25/05/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Updated on 06/08/2004 and displayed until 16/05/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Updated on 23/06/2003 and displayed until 06/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Pneumococcal polysaccharide vaccine